Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.

Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: Arthroscopic rotator cuff repair; Biological: platelet rich plasma

Detailed Description

Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina
    • Hospital Italiano de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI).
• Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids)

Exclusion Criteria:

• Refusal to participate or informed consent,
• Revision surgery,
• Partial repair,
• Patients with shoulder osteoarthritis> 2
• Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4)
• Systemic or rheumatoid arthritis,
• Uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist)
• Acute or chronic infections of the shoulder to be operated on
• Ongoing cancer chemotherapy therapies
• Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
• Previous operations on the affected shoulder,
• Patients with autoimmune diseases;
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arthroscopic rotator cuff repair and platelet rich plasma; A standard double-row arthroscopic rotator cuff repair will be performed and at the end of the procedure 10 ml of autologous platelet-rich plasma will be placed under direct vision at the tendon-bone interface.	Procedure: Arthroscopic rotator cuff repair; A double-row rotator cuff repair will be performed.; Biological: platelet rich plasma; A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.
Active Comparator: Arthroscopic rotator cuff repair; A standard double-row arthroscopic rotator cuff repair will be performed.	Procedure: Arthroscopic rotator cuff repair; A double-row rotator cuff repair will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of re-tear rates between groups.	Postoperative MRI to assess the structural integrity of the repaired rotator cuff.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From baseline in shoulder functional scores at 3, 6 and 12 months	The ASES score (American Shoulder and Elbow Surgeons) and the Constant score will be used. Both scores assess the general function of the shoulder in different activities of daily life, global mobility of the shoulder and pain with usual tasks. They are scores ranging from 0 to 100. Both scores are validated and are the reference scores for clinical research on rotator cuff pathology	baseline, 3, 6, and 12 months
Change From baseline in pain at 3, 6 and 12 months	The visual analog scale (VAS) will be used to assess the level of pain during activities of daily living. 0 will be considered as "no pain" and 10 as "the worst pain of his life."	baseline, 3, 6, and 12 months
Number of Participants With Treatment-Related Adverse Events	Adverse effects and postoperative complications will be recorded.	3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires
• Investigators: Principal Investigator: Luciano Rossi, MD, Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 5702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We are planning on sharing the study protocol and the tables contaning all outcomes for every individual patient
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: The IPD may be requested to the principal investigator contacting him through e-mail at luciano.rossi@hospitalitaliano.org.ar
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No